Biobanking at Birth: Parental Attitudes towards the Use of Perinatal Samples

描述(由申请人提供)：利用出生时收集的生物标本进行研究，整合遗传变异、社会和环境暴露以及健康结果的能力，可能是促进表观遗传学方法预防疾病和促进健康的宝贵资源。在美国和全球，围产期生物库的数量越来越多，包括许多侧重于预防早产、特定儿童状况或出生缺陷的生物库。此外，一些收藏品来自现有的以新生儿及其家人为重点的大规模临床和公共卫生项目。然而，这些样本和数据的收集和使用引发了一些关于捐赠者及其家人的伦理、法律和社会(ELSI)问题。这些问题包括传统的研究伦理问题，如知情同意、捐赠者隐私和研究结果的返回，以及研究人员、IRBs和生物库面临的新挑战，这些人希望从“捐赠者”那里收集样本，这些捐赠者的权利和对其健康信息的控制将随着年龄的增长而改变。该项目有两个主要目标：1)评估准父母和新父母对储存和使用出生时收集的生物样本用于研究目的的态度和信念；2)分析政策、教育材料和围产期收集生物样本计划的同意文件，以评估它们在多大程度上解决了父母对使用这些样本的担忧和愿望。这项研究的参与者将从俄亥俄州克利夫兰一家学术医学中心的产前班招募。该项目将特别关注在出生时收集的三种类型的生物样本：1)作为大型纵向研究计划的一部分收集的生物样本，如国家儿童研究；2)捐赠脐带血储存在公共银行用于潜在移植；3)使用新生儿筛查计划中储存的残余血斑。这项探索性研究的长期目标是利用父母的观点来探索越来越多地使用从新生儿及其家人那里收集的样本和健康数据所带来的ELSI挑战是否表明需要新的方法来管理生物库和保护人类主体。 公共卫生相关性：这项探索性研究将评估准父母和新父母对生物样本和出生时收集的健康信息的储存和使用的态度和信念，以用于未来的研究目的。我们还将分析临床和公共卫生项目的政策、教育材料和同意书，这些项目收集样本进行研究，看看它们是否很好地解决了父母的关切。我们的广泛目标是改进如何要求父母参与使用新生儿样本的研究，以便在保护儿童和家庭的同时促进有价值的研究。

DESCRIPTION (provided by applicant): The ability to utilize biospecimens collected at the time of birth for research that integrates genetic variation, social and environmental exposures, and health outcomes may be an invaluable resource in promoting epigenetic approaches to disease prevention and health promotion. There are a growing number of perinatal biobanks in the US and globally, including many focused on preventing prematurity, specific childhood conditions, or birth defects. Additionally, a number collections are derived from existing large- scale clinical and public health programs focused on newborns and their families. However, the collection and use of these samples and data raise a number of ethical, legal and social (ELSI) concerns regarding the donors and their families. These include traditional research ethics issues, such as informed consent, donor privacy, and the return of research results, as well new challenges for researchers, IRBs, and biobanks wishing to collect samples from "donors" whose rights and control regarding their health information will change as they grow older. This project has two primary aims: 1) To assess the attitudes and beliefs of expectant and new parents about the storage and use of biological specimens collected around the time of birth for research purposes; 2) To analyze policies, educational materials, and consent documents from programs collecting biological specimens within the perinatal period to assess how well they address the concerns and desires of parents regarding the use of these samples. Participants for this study will be recruited from prenatal classes at an academic medical center in Cleveland Ohio. The project will specifically focus on three types of biospecimens collected around the time of birth: 1) biospecimens collected as part of large longitudinal research programs, such as the National Children's Study; 2) umbilical cord blood donated for storage in public banks for potential transplantation; 3) use of stored residual bloodspots from newborn screening programs. The long-term goal of this exploratory study is to utilize parental perspectives to explore whether the ELSI challenges raised by the growing use of samples and health data collected from newborns and their families suggest the need for new approaches to biobanking governance and human subject protections. PUBLIC HEALTH RELEVANCE: This exploratory study will assess the attitudes and beliefs of expectant and new parents about the storage and use of biological samples and health information collected around the time of birth for future research purposes. We will also analyze the policies, educational materials, and consent forms, of clinical and public health programs that collect samples for research to see how well they address parental concerns. Our broad objective is to improve how parents are asked to participate in studies using newborn samples in order to promote valuable research while protecting children and families.